A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Allergan
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01701518
First received: October 3, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.


Condition Intervention
Epiretinal Membrane
Macular Edema
Drug: Ozurdex

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.


Secondary Outcome Measures:
  • Best corrected visual acuity at 1,4 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.

  • Retinal thickness and volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).

  • Intraocular pressure (IOP) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change of IOP from baseline will be monitored.

  • Cataract progression (if applicable) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.


Estimated Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ozurdex
Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
Drug: Ozurdex
biodegradable 0.7mg dexamethasone implant
Other Name: 0.7mg dexamethasone implant

Detailed Description:

We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.

This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
  • Central retinal thickness ≥ 250 μm.
  • Age more than 18 years old.
  • Decision makers able to give informed consent.
  • Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.

Exclusion Criteria:

  • Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
  • Any other macular pathology that could affect anatomic or functional results.
  • History of uveitis requiring intravitreal triamcinolone injection.
  • History of steroid-responsive glaucoma.
  • History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
  • IOP > 23 mm Hg if untreated, or > 21 mm Hg if treated with medication.
  • Pregnant or breast-feeding woman.
  • Unable to attend the scheduled follow-up appointments.
  • Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
  • Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701518

Contacts
Contact: Charlene Muller 416-480-5091 charlene.muller@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Charlene Muller    416-480-5091    charlene.muller@sunnybrook.ca   
Principal Investigator: Peter J Kertes, MD,CM,FRCSC         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Rajeev Muni, MD, FRCSC    (416) 867-7422    rajeev.muni@utoronto.ca   
Principal Investigator: Rajeev Muni, MD,FRCSC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
Allergan
Investigators
Principal Investigator: Peter J Kertes, MD,CM,FRCSC Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01701518     History of Changes
Other Study ID Numbers: OZ123, OZ123
Study First Received: October 3, 2012
Last Updated: October 3, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Ozurdex
Dexamethasone
Epiretinal membrane
Macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014